Quality Engineer

HERO Recruitment; Galway; On-site; EUR 55,000 - 75,000; Full time

Job summary

HERO Recruitment is seeking a motivated Quality Engineer for our Galway-based client in Ireland. You will provide quality engineering support across operational and project activities, ensuring compliance with GMP, ISO, and regulatory requirements within a regulated manufacturing environment.

You will lead investigations of quality events and CAPAs, review quality documentation, support change control, and drive continuous improvement through Lean/Six Sigma methodologies.

Qualifications

• Bachelor's degree in Engineering, Science, Quality, or a related discipline.
• Experience in a regulated manufacturing environment (pharmaceutical, medical device, biotechnology, or similar).
• Strong documentation and analytical skills.
• Experience with CAPA, deviations, change control, and risk management.
• Familiarity with regulatory requirements (FDA, EU GMP, ISO 13485 or ISO 9001).
• Strong communication and stakeholder management.

Responsibilities

• Provide day-to-day quality engineering support to manufacturing operations.
• Investigate quality events, deviations, non-conformances, and customer complaints.
• Support root cause analysis and CAPA implementation.
• Review and approve quality documentation (procedures, work instructions, batch records).
• Support change control activities and assess quality impact.
• Monitor quality metrics and drive continuous improvement.
• Develop, review, and execute validation documentation (IQ, OQ, PQ, Process Validation).
• Support equipment, utility, and process qualification activities.
• Act as the Quality representative on cross-functional project teams.
• Support new product introductions, technology transfers, and facility upgrades.
• Review and approve project documentation from a quality perspective.

Skills

GMP knowledge

CAPA

Regulatory awareness

Quality tooling

Analytical thinking

Cross-functional collaboration

Documentation skills

Education

Bachelor's degree in Engineering, Science, Quality, or related discipline

Tools

eQMS

Job description

We are seeking a motivated and experienced Quality Engineer to join our Quality team. The successful candidate will provide quality engineering support across both operational and project activities, ensuring compliance with regulatory requirements, quality standards, and company procedures. This role requires a balanced mix of validation expertise, project experience, and operational quality support within a regulated manufacturing environment.

Key Responsibilities

Quality Operations

• Provide day-to-day quality engineering support to manufacturing operations.
• Investigate quality events, deviations, non-conformances, and customer complaints.
• Support root cause analysis and implementation of effective corrective and preventive actions (CAPA).
• Review and approve quality documentation, including procedures, work instructions, and batch records where applicable.
• Support change control activities and assess quality impact.
• Monitor quality metrics and identify opportunities for continuous improvement.

Validation & Qualification

• Develop, review, and execute validation documentation, including:Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Process Validation
• Cleaning Validation (where applicable)
• Support equipment, utility, and process qualification activities.
• Ensure validation activities comply with regulatory and company requirements.

Project Support

• Act as the Quality representative on cross-functional project teams.
• Support new product introductions, technology transfers, and facility or equipment upgrades.
• Review and approve project documentation from a quality perspective.
• Ensure quality requirements are incorporated throughout the project lifecycle.
• Participate in project risk assessments and design reviews.

Compliance & Continuous Improvement

• Ensure compliance with applicable GMP, ISO, and regulatory requirements.
• Support internal and external audits and regulatory inspections.
• Participate in continuous improvement initiatives using Lean, Six Sigma, or similar methodologies.
• Promote a quality culture across the organisation.

Qualifications

• Bachelor's degree in Engineering, Science, Quality, or a related discipline.
• Minimum of 3–5 years' experience in a regulated manufacturing environment (pharmaceutical, medical device, biotechnology, or similar).
• Experience in both quality operations and validation activities.
• Previous project experience supporting new equipment, process improvements, or capital projects is highly desirable.

Knowledge & Experience

• Strong understanding of GMP and quality management systems.
• Experience with validation lifecycle principles.
• Knowledge of CAPA, deviations, change control, and risk management.
• Experience with internal and external audits.
• Familiarity with regulatory requirements, including FDA, EU GMP, ISO 13485, or ISO 9001 (as applicable).
• Strong documentation and technical writing skills.
• Strong analytical and problem-solving skills.
• Excellent communication and stakeholder management.
• Ability to work effectively in cross-functional teams.
• High attention to detail and commitment to quality.
• Strong planning and organisational skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Experience with statistical analysis and quality tools.
• Experience supporting digital quality systems (eQMS).
• Knowledge of data integrity and electronic quality management systems.